Researcher Shruti Dave (right) and assistant Chetan Patel work on stem cell cultures at the Transplantation Biology Research Centre at The Institute of Kidney Disease and Research Centre (IKDRC), Civil Hospital campus in Ahmedabad on February 6, 2013. The Philippine College of Physicians wants the Food and Drug Administration to more strictly regulate the use of stem cell therapy, which was being “wrongfully projected as a cure-all.” AFP FILE PHOTO
Docs seek stop to expensive, experimental stem cell therapy
MANILA, Philippines—Saying that doctors were exacting “exorbitant fees” for what is still experimental medicine, the Philippine College of Physicians (PCP) launched Tuesday an online petition urging the Department of Health (DOH) to put a stop to “experimental” stem cell therapies in the country.
“Human stem cell therapy for unproven indications is proliferating in the Philippines and posing serious safety issues to unknowing Filipinos… The Philippine College of Physicians is alarmed by the false claims, misinformation and exorbitant fees for such stem cell treatments,” read the petition on www.change.org.
The PCP urged the DOH to issue a cease and desist order to all doctors performing such therapies as the Philippine Health Insurance Corp. (PhilHealth) clarified that stem cell therapy was not covered by the government’s universal healthcare program.
Cease and desist
“We, the undersigned, call on the (DOH) to issue a cease and desist order to all doctors, clinics and hospitals that [offer] human stem cell therapy for unproven indications until scientific evidence to support claims of efficacy and safety are approved by the Food and Drug Administration,” it said.
The PCP, the umbrella organization of Internal Medicine specialists in the country, said that transplanting “human blood-forming stem cells” to treat cancerous and noncancerous diseases of the blood was the most widely accepted clinical application of stem cell therapy.
“The effectiveness and safety of human stem cell therapy has yet to be proven for heart, neurologic, skin, rheumatologic and gastrointestinal diseases, diabetes, hypertension, autism, cancer, aging and aesthetics, HIV/AIDS and other conditions,” the group said.
Lack of evidence
“Despite the lack of solid scientific evidence to support the [application] of human stem cell therapy for these conditions, reports of its use precisely for these conditions being received and exorbitant fees being paid by prominent personalities abound in media,” the PCP said.
It said that this could mislead the public into accepting stem cell therapy which “is at best experimental at this time.”
“Good ethical practice dictates that when treatment is experimental, the patient should not pay for it but instead should be compensated for altruism in participating in a clinical trial for a treatment that has not yet been proven completely effective or safe,” the PCP said.
“The use of human stem cells for unproven indications should be confined to clinical studies that have been screened and approved by a duly constituted technical review board and ethics committee,” it further said.
The group said that human stem cell therapies should be duly registered with the FDA and performed only in DOH-accredited centers.
PhilHealth says no
PhilHealth, meanwhile, said it was not paying for stem cell therapy but if it were later certified as “a standard care,” it would have to undergo evaluation first.
Under Republic Act No. 10606, the law creating the National Health Insurance Program of 2013, as amended, “the Corporation [PhilHealth] shall not cover expenses for health services considered … as cost ineffective through health technology assessment … in keeping with its protection objectives and financial sustainability.”
“All new technologies, including stem cell therapy, shall undergo the process of assessment if they can be developed into a benefit package or be excluded from the same,” PhilHealth said.